Halsa has acquired the exclusive intellectual property rights to ZAG, a material naturally found in humans, which induces immediate and substantial depletion of body fat as well as control of diabetic symptoms. A growing set of evidence shows that this therapeutic works in depleting body fat. Over 65% of Americans are overweight or obese, the costs of these conditions is estimated as $150 billion (half in actual health care costs), and the market for an effective prescription weight-loss therapeutic is estimated at $18 billion annually. Halsa has assembled a world-class team with exact domain expertise in pharmaceutical drug development. This project will lay the foundation for ZAG to enter full preclinical trials in preparation of an IND filing with the FDA, and subsequent clinical trials. This SBIR Phase I project will result in exploratory GLP toxicological studies in rats, a critical step in understanding possible liabilities for this promising therapeutic agent. The three specific aims of this project are: manufacture of the biologic agent, determination of its potency and toxicology studies including histopathology. PUBLIC HEALTH RELEVANCE: Obesity and overweight are epidemic, dangerous, expensive and largely untreated. Halsa is developing a biological drug, ZAG, a material naturally found in humans, which induces immediate and substantial depletion of body fat and also controls symptoms of diabetes. This therapeutic candidate has the potential to treat the nearly 200 million Americans afflicted with these deleterious metabolic diseases.